Diffuse Large B Cell LymphomaPhase 2NCT06516978
A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL
A Phase 2 study testing Polatuzumab vedotin, Rituximab and Cyclophosphamide in people with Diffuse Large B Cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
This study aims to compare the efficacy and safety of Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone combined with Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1 (Pola-RCHP-X) versus RCHOP-X and Pola-RCHP in previously untreated patients with DLBCL. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Polatuzumab vedotin, Rituximab and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent form
- Previously untreated participants with CD20-positive DLBCL
- Life expectancy ≥ 6 months
- IPI score 2-5
- ECOG Performance Status of 0, 1, or 2
- Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
- Adequate hematologic function (unless due to underlying disease, as established for example, by extensive bone marrow involvement or due to hypersplenism secondary to involvement of the spleen by DLBCL per the investigator for which blood product transfusions are permitted) defined as follows:
- Hemoglobin ≥ 9.0 g/dL without packed RBC transfusion during 7 days before first treatment ANC ≥ 1.0 x 10^9/L PLT ≥ 75 x 10^9/L
Who cannot join
- Contraindication to any of the individual components of Pola-RCHP or Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1
- History of other malignancy that could affect compliance with the protocol or interpretation of results
- Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina
- History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
- Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety
- Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):
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- Serum AST and ALT ≥ 2.5 x ULN Total bilirubin ≥ 1.5 x ULN Serum creatinine clearance < 40 mL/min (using Cockcroft-Gault formula)
- Suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)
- Participants with a history of progressive multifocal leukoencephalopathy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Open-Label, Multicenter, Randomized Controlled Study Comparing the Efficacy and Safety of Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Combined With Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1 (Pola-RCHP-X) Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma
This study aims to compare the efficacy and safety of Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone combined with Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1 (Pola-RCHP-X) versus RCHOP-X and Pola-RCHP in previously untreated patients with DLBCL.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polatuzumab vedotinDrug
Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
RituximabDrug
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
CyclophosphamideDrug
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
DoxorubicinDrug
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
VincristineDrug
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
PrednisoneDrug
Prednisone PO will be administered as per the schedule specified in the respective arm.
OrelabrutinibDrug
Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
VenetoclaxDrug
Venetoclax PO will be administered as per the schedule specified in the respective arm.
ChidamideDrug
Chidamide PO will be administered as per the schedule specified in the respective arm.
PenpulimabDrug
Penpulimab IV infusion will be administered as per the schedule specified in the respective arm.
LenalidomideDrug
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
| Study group | Role | What they receive |
|---|---|---|
| Pola-RCHP-X | Experimental | From cycles 1 to 6, patients will receive Polatuzumab Vedotin 1.8 mg/kg, Rituximab 375 mg/m², Cyclophosphamide 750 mg/m², and Doxorubicin 50 mg/m² on day 1 of each cycle, and Prednisone 100 mg/day from days 1 to 5. From cycles 2 to 6, patients will receive either Orelabrutinib 150 mg/day (days 1-21), Venetoclax 800 mg (days 4-10 in cycle 2; days 1-10 in cycles 3-6), Chidamide 20 mg/day (days 1, 4, 8, 11), Penpulimab 200 mg/day (day 0), or Lenalidomide 25 mg/day (days 1-10). In cycles 7 to 8, patients will receive Rituximab 375 mg/m² on day 1 of each cycle. Receives: Drug: Polatuzumab vedotin; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone; Drug: Orelabrutinib; Drug: Venetoclax; Drug: Chidamide; Drug: Penpulimab; Drug: Lenalidomide |
| RCHOP-X | Active comparator | From cycles 1 to 6, patients will receive Rituximab 375 mg/m², Cyclophosphamide 750 mg/m², Doxorubicin 50 mg/m², and Vincristine 1.4 mg/m² on day 1 of each cycle, and Prednisone 100 mg/day from days 1 to 5. From cycles 2 to 6, patients will receive either Orelabrutinib 150 mg/day (days 1-21), Venetoclax 800 mg (days 4-10 in cycle 2; days 1-10 in cycles 3-6), Chidamide 20 mg/day (days 1, 4, 8, 11), Penpulimab 200 mg/day (day 0), or Lenalidomide 25 mg/day (days 1-10). In cycles 7 to 8, patients will receive Rituximab 375 mg/m² on day 1 of each cycle. Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Orelabrutinib; Drug: Venetoclax; Drug: Chidamide; Drug: Penpulimab; Drug: Lenalidomide |
| Pola-RCHP | Active comparator | From cycles 1 to 6, patients will receive Polatuzumab Vedotin at 1.8 mg/kg, Rituximab at 375 mg/m², Cyclophosphamide at 750 mg/m², and Doxorubicin at 50 mg/m² on day 1 of each cycle, and Prednisone at 100 mg/day from days 1 to 5. In cycles 7 to 8, patients will receive Rituximab at 375 mg/m² on day 1 of each cycle. Receives: Drug: Polatuzumab vedotin; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival at 24 months (PFS24) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Measured: At 24 months
Secondary outcomes (5)
Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Measured: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days]
Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Measured: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days]
Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Measured: up to approximately 48 months
Overall Survival (OS)
Measured: up to approximately 48 months
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From enrollment to study completion, a maximum of 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 528 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WEI XU, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516978
- Sponsor's protocol ID
- 2024-SR-436
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Multicenter, Randomized Controlled Study Comparing the Efficacy and Safety of Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Combined With Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1 (Pola-RCHP-X) Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06516978
- Acronym / sponsor ID
- 2024-SR-436
- Conditions
- Diffuse Large B Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 528 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the efficacy and safety of Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone combined with Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1 (Pola-RCHP-X) versus RCHOP-X and Pola-RCHP in previously untreated patients with DLBCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pola-RCHP-X | Experimental | Drug: Polatuzumab vedotin, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Prednisone, Drug: Orelabrutinib, Drug: Venetoclax, Drug: Chidamide, Drug: Penpulimab, Drug: LenalidomideFrom cycles 1 to 6, patients will receive Polatuzumab Vedotin 1.8 mg/kg, Rituximab 375 mg/m², Cyclophosphamide 750 mg/m², and Doxorubicin 50 mg/m² on day 1 of each cycle, and Prednisone 100 mg/day from days 1 to 5. From cycles 2 to 6, patients will receive either Orelabrutinib 150 mg/day (days 1-21), Venetoclax 800 mg (days 4-10 in cycle 2; days 1-10 in cycles 3-6), Chidamide 20 mg/day (days 1, 4, 8, 11), Penpulimab 200 mg/day (day 0), or Lenalidomide 25 mg/day (days 1-10). In cycles 7 to 8, patients will receive Rituximab 375 mg/m² on day 1 of each cycle. |
| RCHOP-X | Active comparator | Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone, Drug: Orelabrutinib, Drug: Venetoclax, Drug: Chidamide, Drug: Penpulimab, Drug: LenalidomideFrom cycles 1 to 6, patients will receive Rituximab 375 mg/m², Cyclophosphamide 750 mg/m², Doxorubicin 50 mg/m², and Vincristine 1.4 mg/m² on day 1 of each cycle, and Prednisone 100 mg/day from days 1 to 5. From cycles 2 to 6, patients will receive either Orelabrutinib 150 mg/day (days 1-21), Venetoclax 800 mg (days 4-10 in cycle 2; days 1-10 in cycles 3-6), Chidamide 20 mg/day (days 1, 4, 8, 11), Penpulimab 200 mg/day (day 0), or Lenalidomide 25 mg/day (days 1-10). In cycles 7 to 8, patients will receive Rituximab 375 mg/m² on day 1 of each cycle. |
| Pola-RCHP | Active comparator | Drug: Polatuzumab vedotin, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: PrednisoneFrom cycles 1 to 6, patients will receive Polatuzumab Vedotin at 1.8 mg/kg, Rituximab at 375 mg/m², Cyclophosphamide at 750 mg/m², and Doxorubicin at 50 mg/m² on day 1 of each cycle, and Prednisone at 100 mg/day from days 1 to 5. In cycles 7 to 8, patients will receive Rituximab at 375 mg/m² on day 1 of each cycle. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Sign the informed consent form
- Previously untreated participants with CD20-positive DLBCL
- Life expectancy ≥ 6 months
- IPI score 2-5
- ECOG Performance Status of 0, 1, or 2
Key exclusion criteria (9 listed)
- Contraindication to any of the individual components of Pola-RCHP or Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1
- History of other malignancy that could affect compliance with the protocol or interpretation of results
- Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina
- History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
- Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polatuzumab vedotinPolatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Pola-RCHP, Pola-RCHP-X |
| RituximabRituximab IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Pola-RCHP, Pola-RCHP-X, RCHOP-X |
| CyclophosphamideCyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Pola-RCHP, Pola-RCHP-X, RCHOP-X |
| DoxorubicinDoxorubicin IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Pola-RCHP, Pola-RCHP-X, RCHOP-X |
| VincristineVincristine IV infusion will be administered as per the schedule specified in the respective arm. | Drug | RCHOP-X |
| PrednisonePrednisone PO will be administered as per the schedule specified in the respective arm. | Drug | Pola-RCHP, Pola-RCHP-X, RCHOP-X |
| OrelabrutinibOrelabrutinib PO will be administered as per the schedule specified in the respective arm. | Drug | Pola-RCHP-X, RCHOP-X |
| VenetoclaxVenetoclax PO will be administered as per the schedule specified in the respective arm. | Drug | Pola-RCHP-X, RCHOP-X |
| ChidamideChidamide PO will be administered as per the schedule specified in the respective arm. | Drug | Pola-RCHP-X, RCHOP-X |
| PenpulimabPenpulimab IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Pola-RCHP-X, RCHOP-X |
| LenalidomideLenalidomide PO will be administered as per the schedule specified in the respective arm. | Drug | Pola-RCHP-X, RCHOP-X |
Primary outcome
Progression Free Survival at 24 months (PFS24) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Time frame: At 24 months
5 secondary outcomes
Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days]
Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days]
Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Time frame: up to approximately 48 months
Overall Survival (OS)
Time frame: up to approximately 48 months
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From enrollment to study completion, a maximum of 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polatuzumab vedotin, Rituximab and Cyclophosphamide in people with Diffuse Large B Cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Xu (+8602568306034, xuwei10000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival at 24 months (PFS24) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma (time frame: At 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.